(273 days)
Not Found
FKX
Unknown
The device name "Intelligent Dialysis Assistant (IDA)" suggests potential AI/ML, but the provided text does not explicitly mention AI, ML, or related terms, nor does it describe any AI/ML-specific components or functionalities.
Yes.
The device is intended for the automatic single exchange of dialysate solution in the treatment of adult renal failure patients undergoing peritoneal dialysis, which is a therapeutic intervention.
No
The device, Intelligent Dialysis Assistant (IDA), is described as being for automatic single exchange of dialysate solution in the treatment of renal failure patients undergoing peritoneal dialysis. Its function is treatment delivery, and while it interacts with data for treatment review and prescription management, it does not perform diagnosis of a medical condition.
No
The description clearly mentions the "Intelligent Dialysis Assistant (IDA)" and the "IDA Cartridge," which are hardware components. While there is a "Medical Supervision Portal" and an "IDA Smartphone App" described as software, the overall system includes hardware for performing the dialysis exchanges.
Based on the provided information, the Intelligent Dialysis Assistant (IDA) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- IDA's Function: The IDA is described as a device for "automatic single exchange of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis." This is a therapeutic treatment process, not a diagnostic test performed on a sample.
- Components: The components mentioned (IDA Cartridge, Twin Bag Set, peritoneal catheter) are all involved in the physical process of peritoneal dialysis, which is a method of filtering waste products from the blood using the peritoneum as a membrane.
- Software Components: The Medical Supervision Portal and IDA Smartphone App are for managing and reviewing treatment parameters and results, not for performing diagnostic tests.
Therefore, the IDA falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) & IDA Cartridge with Medical Supervision Portal and IDA Smartphone App
Intelligent Dialysis Assistant (IDA) is intended for automatic single exchange of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis.
All therapies using the Intelligent Dialysis Assistant (IDA) must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis. The patient prescription may include single or multiple exchanges, depending on the patient's need.
The IDA Cartridge is a single-use, sterile cartridge exclusively for use with the IDA. It is intended to interface the IDA with the Twin Bag Set (patient dialysis prescription) and the patient's peritoneal catheter.
The Medical Supervision Portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment database to aid in the review, analysis, and evaluation of patients' historical treatment results. This Medical Supervision Portal is not intended to be a substitute for good clinical management practices, nor does its operation creatment pathways.
The IDA Smartphone App is a software medical application intended for patients to review their treatment and review and approve their dialysis prescription provided by the healthcare professional through the Medical Supervision Portal. The user is not intended to take clinical action based on the application of a qualified healthcare professional.
Product codes
FKX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
adult
Intended User / Care Setting
Physician, healthcare professionals, patients
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
December 29, 2022
liberDi, Ltd % Wanda Carpinella Principle Regulatory Consultant Insight Medical Consulting, LLC 7 Barrows Road Shrewsbury, MA 01545
Re: K220935
Trade/Device Name: Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) & IDA Cartridge with Medical Supervision Portal and IDA Smartphone App Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: Class II Product Code: FKX Dated: March 30, 2022 Received: March 31, 2022
Dear Wanda Carpinella:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Jade M. Noble -S
for
Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220935
Device Name
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) & IDA Cartridge with Medical Supervision Portal and IDA Smartphone App
Indications for Use (Describe)
Intelligent Dialysis Assistant (IDA) is intended for automatic single exchange of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis.
All therapies using the Intelligent Dialysis Assistant (IDA) must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis. The patient prescription may include single or multiple exchanges, depending on the patient's need.
The IDA Cartridge is a single-use, sterile cartridge exclusively for use with the IDA. It is intended to interface the IDA with the Twin Bag Set (patient dialysis prescription) and the patient's peritoneal catheter.
The Medical Supervision Portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment database to aid in the review, analysis, and evaluation of patients' historical treatment results. This Medical Supervision Portal is not intended to be a substitute for good clinical management practices, nor does its operation creatment pathways.
The IDA Smartphone App is a software medical application intended for patients to review their treatment and review and approve their dialysis prescription provided by the healthcare professional through the Medical Supervision Portal. The user is not intended to take clinical action based on the application of a qualified healthcare professional.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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